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NCT Number: NCT03500042

Effects of Different Modes of Respiratory MuscleTraining on Respiratory Mechanics and NRD in Patient With Stable COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease characterized by persistent airflow limitation. The patients are suffering dyspnea year by year, resulting in the decreased exercise tolerance and quality of life. Patients with COPD often have both inspiratory muscles and expiratory muscle dysfunction. Respiratory muscle training was one of the widely used pulmonary rehabilitation method in COPD patients. Respiratory muscle training include inspiratory training ,expiratory training and concurrent inspiratory and expiratory muscle training . Both of the training methods are effective. However, the effects of these different types of respiratory muscle training method on the respiratory physiology and neural respiratory drive of COPD are still unclear. Therefore, the purpose of this study was to investigate the different effects of these respiratory muscle training methods on respiratory mechanics and central drive in COPD patients. Besides,the effect of the different respiratory muscle training methods was compared between patients with and without respiratory muscle weakness.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

About this study

The patients with COPD will participate in a rehabilitation program including inspiratory muscle training, expiratory muscle training and concurrent inspiratory and expiratory muscle training.

The outcome measures are the classic respiratory mechanics indicators and respiratory center drive.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion criteria

  • Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed.

Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction

Treatment and study plan

inspiratory pressure threshold device

Device

The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.

Other names: expiratory pressure threshold device, concurrent inspiratory and expiratory muscle device

Primary outcomes

  1. Diaphragmatic function

    Time frame: Change from baseline in diaphragm electromyogram at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

    Diaphragmatic function can be assessed by diaphragm electromyogram(EMGdi) which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.

Secondary outcomes

  1. Respiratory pressure

    Time frame: Change from baseline in respiratory pressure at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

    Respiratory pressure parameter is transdiaphragmatic pressure ( Pdi) in cmH2O, which reflect the strength of diaphragm.

  2. Respiratory volume

    Time frame: Change from baseline in respiratory volume at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

    Respiratory volume parameter is minute ventilation (VE) in liter(L).

  3. respiratory work

    Time frame: Change from baseline in transdiaphragmatic pressure time product at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

    respiratory work is associated with transdiaphragmatic pressure time product

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

Effects of Different Modes of Respiratory Muscular Threshold Loads Training on Respiratory Mechanics and Neural Respiratory Drive(NRD) in Patient With Stable Chronic Obstructive Pulmonary Disease(COPD).

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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